Hepatitis A Exposure at Restaurant in Nyack, NY

Seems like it’s the season for hepatitis A. A confirmed case of acute hepatitis A has been identified in a food handler at the La Fontana restaurant in Nyack, New York. Anyone who ate there between March 19 and April 1, 2014 may have been exposed to hepatitis A.

The County of Rockland Department of Health is recommending that everyone who ate at the restaurant on March 29, March 30, or April 1, 2014 receive a vaccination. The vaccination is about 80% to 90% effective. The Rockland County Department of Health is offering free vaccines to patrons and employees of the restaurant on Sunday, April 13, 2014 from 11:00 am to 3:00 pm and Monday, April 14, 2014 from 9:00 am to 12:00 pm at the Rockland County Fire Training Center at 35 Firemens Memorial Drive in Pomona.

What the Tamiflu saga tells us about drug trials and big pharma

We now know the government’s Tamiflu stockpile wouldn’t have done us much good in the event of a flu epidemic. But the secrecy surrounding clinical trials means there’s a lot we don’t know about other medicines we take

Today we found out that Tamiflu doesn’t work so well after all. Roche, the drug company behind it, withheld vital information on its clinical trials for half a decade, but the Cochrane Collaboration, a global not-for-profit organisation of 14,000 academics, finally obtained all the information. Putting the evidence together, it has found that Tamiflu has little or no impact on complications of flu infection, such as pneumonia.

That is a scandal because the UK government spent £0.5bn stockpiling this drug in the hope that it would help prevent serious side-effects from flu infection. But the bigger scandal is that Roche broke no law by withholding vital information on how well its drug works. In fact, the methods and results of clinical trials on the drugs we use today are still routinely and legally being withheld from doctors, researchers and patients. It is simple bad luck for Roche that Tamiflu became, arbitrarily, the poster child for the missing-data story.

And it is a great poster child. The battle over Tamiflu perfectly illustrates the need for full transparency around clinical trials, the importance of access to obscure documentation, and the failure of the regulatory system. Crucially, it is also an illustration of how science, at its best, is built on transparency and openness to criticism, because the saga of the Cochrane Tamiflu review began with a simple online comment.

In 2009, there was widespread concern about a new flu pandemic, and billions were being spent stockpiling Tamiflu around the world. Because of this, the UK and Australian governments specifically asked the Cochrane Collaboration to update its earlier reviews on the drug. Cochrane reviews are the gold-standard in medicine: they summarise all the data on a given treatment, and they are in a constant review cycle, because evidence changes over time as new trials are published. This should have been a pretty everyday piece of work: the previous review, in 2008, had found some evidence that Tamiflu does, indeed, reduce the rate of complications such as pneumonia. But then a Japanese paediatrician called Keiji Hayashi left a comment that would trigger a revolution in our understanding of how evidence-based medicine should work. This wasn’t in a publication, or even a letter: it was a simple online comment, posted informally underneath the Tamiflu review on the Cochrane website, almost like a blog comment.

Cochrane had summarised the data from all the trials, explained Hayashi, but its positive conclusion was driven by data from just one of the papers it cited: an industry-funded summary of 10 previous trials, led by an author called Kaiser. From these 10 trials, only two had ever been published in the scientific literature. For the remaining eight, the only available information on the methods used came from the brief summary in this secondary source, created by industry. That’s not reliable enough.

This is science at its best. The Cochrane review is readily accessible online; it explains transparently the methods by which it looked for trials, and then analysed them, so any informed reader can pull the review apart, and understand where the conclusions came from. Cochrane provides an easy way for readers to raise criticisms. And, crucially, these criticisms did not fall on deaf ears. Dr Tom Jefferson is the head of the Cochrane respiratory group, and the lead author on the 2008 review. He realised immediately that he had made a mistake in blindly trusting the Kaiser data. He said so, without defensiveness, and then set about getting the information needed.

First, the Cochrane researchers wrote to the authors of the Kaiser paper. By reply, they were told that this team no longer had the files: they should contact Roche. Here the problems began. Roche said it would hand over some information, but the Cochrane reviewers would need to sign a confidentiality agreement. This was tricky: Cochrane reviews are built around showing their working, but Roche’s proposed contract would require them to keep the information behind their reasoning secret from readers. More than this, the contract said they were not allowed to discuss the terms of their secrecy agreement, or publicly acknowledge that it even existed. Roche was demanding a secret contract, with secret terms, requiring secrecy about the methods and results of trials, in a discussion about the safety and efficacy of a drug that has been taken by hundreds of thousands of people around the world, and on which governments had spent billions. Roche’s demand, worryingly, is not unusual. At this point, many in medicine would either acquiesce, or give up. Jefferson asked Roche for clarification about why the contract was necessary. He never received a reply.

Then, in October 2009, the company changed tack. It would like to hand over the data, it explained, but another academic review on Tamiflu was being conducted elsewhere. Roche had given this other group the study reports, so Cochrane couldn’t have them. This was a non-sequitur: there is no reason why many groups should not all work on the same question. In fact, since replication is the cornerstone of good science, this would be actively desirable.

Then, one week later, unannounced, Roche sent seven documents, each around a dozen pages long. These contained excerpts of internal company documents on each of the clinical trials in the Kaiser meta-analysis. It was a start, but nothing like the information Cochrane needed to assess the benefits, or the rate of adverse events, or fully to understand the design of the trials.

Packets of Tamiflu in a drawer at a German pharmacy. Photograph: Wolfgang Rattay/Reuters At the same time, it was rapidly becoming clear that there were odd inconsistencies in the information on this drug. Crucially, different organisations around the world had drawn vastly different conclusions about its effectiveness. The US Food and Drug Administration (FDA) said it gave no benefits on complications such as pneumonia, while the US Centers for Disease Control and Prevention said it did. The Japanese regulator made no claim for complications, but the European Medicines Agency (EMA) said there was a benefit. There are only two explanations for this, and both can only be resolved by full transparency. Either these organisations saw different data, in which case we need to build a collective list, add up all the trials, and work out the effects of the drug overall. Or this is a close call, and there is reasonable disagreement on how to interpret the trials, in which case we need full access to their methods and results, for an informed public debate in the medical academic community.

This is particularly important, since there can often be shortcomings in the design of a clinical trial, which mean it is no longer a fair test of which treatment is best. We now know this was the case in many of the Tamiflu trials, where, for example, participants were sometimes very unrepresentative of real-world patients. Similarly, in trials described as “double blinded” – where neither doctor nor patient should be able to tell whether they’re getting a placebo or the real drug – the active and placebo pills were different colours. Even more oddly, in almost all Tamiflu trials, it seems a diagnosis of pneumonia was measured by patients’ self-reporting: many researchers would have expected a clear diagnostic algorithm, perhaps a chest x-ray, at least.

Since the Cochrane team were still being denied the information needed to spot these flaws, they decided to exclude all this data from their analysis, leaving the review in limbo. It was published in December 2009, with a note explaining their reasoning, and a small flurry of activity followed. Roche posted their brief excerpts online, and committed to make full study reports available. For four years, they then failed to do so.

Row erupts over influenza drug Tamiflu

Tamiflu is on the World Health Organisation’s ‘essential medicines’ list (Flickr: kanonn)

Governments who stockpile the anti-flu medicine Tamiflu are wasting billions of dollars on a drug whose effectiveness is in doubt, according to a new study.

The row has drawn in the drugmaker Roche, as well as industry regulators and independent scientists. Supporters of Tamiflu says the review’s conclusions are flawed and insiste the drug is both safe and effective.

The dispute over the benefits of Tamiflu, and to a lesser extent of GlaxoSmithKline’s flu drug Relenza, blew up with the joint publication by the respected Cochrane Review research network and the British Medical Journal of an analysis of trial data, which found no good evidence behind claims the drugs cut hospital admissions or reduce flu complications.

The review’s main findings were that the medicines had few if any beneficial effects, but did have adverse side effects that were previously dismissed or overlooked.

“Remember, the idea of a drug is that the benefits should exceed the harms,” says Carl Heneghan, one of the lead investigators of the Cochrane review and a professor of evidence-based medicine at Britain’s Oxford University. “So if you can’t find any benefits, that accentuates the harms.”

But Roche, which has been under fire for several years over its refusal to allow the Cochrane team unrestricted access to Tamiflu data, rejected the findings, saying it “fundamentally disagrees with the overall conclusions” of their study.

“We firmly stand by the quality and integrity of our data, reflected in decisions reached by 100 regulators across the world and subsequent real-world evidence demonstrating that Tamiflu is an effective medicine in the treatment and prevention of influenza,” it says in a statement.

Tamiflu sales hit almost $3 billion in 2009 — mostly due to its use in the H1N1 flu pandemic — but they have since declined.

The drug, one of a class of medicines known as neuraminidase inhibitors, is approved by regulators worldwide and is stockpiled in preparation for a potential global flu outbreak. It is also on the World Health Organisation’s “essential medicines” list.

Did you know that genetically engineered vaccines are approved for use in livestock for the USDA National Organic Program? Straight from the horse’s mouth:

At present, the National List identifies all vaccines, as a group, as synthetic substances allowed for use in organic livestock production. Vaccines are not individually listed on the National List, but rather are included on as a group of synthetic substances termed “Biologics Vaccines,” that may be used in organic livestock production (7 CFR §205.603(a)(4)).

USDA.gov

Vaccines

Made

from

Genetically Modified Organisms

Livestock

___________________________________

Composition

of the Substance

:

GMO vaccines are composed of inactivated or weakened viral or bacterial organisms

thathave had genetic material added, deleted, or otherwise modified. Vaccines may also contain suspending fluids, adjuvants (additives that help stimulate an immune response, most commonly aluminum salts and oil/water mixtures) stabilizers, preservatives, or other substances to improve shelf – life and effectiveness of the vaccine(CDC, 2011)

.

Additives in GMO vaccines do not differ from conventional vaccines

(OIE, 2010)

Approved Legal Uses of the Substance:

Under regulations issued by the USDA’s National Organic Program (NOP) pursuant to the Organic Food Production Act of 1990, genetic modification is considered an “excluded method,”which is generally prohibited from organic production and handling under 7 CFR 205.105(e). However, the prohibition of excluded methods includes an exception for vaccines with the condition that the vaccines are approved

in accordance with §205.600(a). That is, the vaccines must be included on the

List of Allowed and Prohibited Substances (hereafter referred to as the National List)

.

At present, the National List identifies all vaccines, as a group, as synthetic substances allowed for use in organic livestock production (7 CFR §205.603(a)(4))

.

Vaccines are not individually listed on the National List, but rather are included on as a group of synthetic substances termed “Biologics — Vaccines” that may be used in organic livestock production (7 CFR §205.603(a)(4))

.

According to livestock health care standards specified in 7 CFR §205.238, organic livestock producers must establish and main preventive healthcare practices including vaccinations. In addition, 7 CFR §205.238 specifies that any animal drug other than vaccinations cannot be administered in the absence of illness

.

Any animal treated with antibiotics may not be sold, labeled, or represented as an organic (205.238(c)(7)).

Livestock vaccines are regulated by the USDA’s Animal and Plant Health Inspection Service (APHIS) Center for Veterinary Biologics under authority of the Virus-Serum-

Toxin Act of 1913. In particular, all vaccines used in agricultural animals must be licensed, and vaccines created using biotechnology (i.e., made with GMOs) must adhere to the same standards for traditional vaccines. Specifically, vaccine makers

are required to submit a Summary Information Format (SIF) specific to the type of vaccine (Roth and Henderson, 2001). A SIF must present information regarding t

he efficacy, safety, and environmental impact of the vaccine being registered. The purpose of the SIF is to characterize the vaccine’s potential for, and likelihood of, risk. Occasionally, peer-review panels are formed to complete risk assessment of

vaccines; this was the case for the currently licensed live vector rabies vaccine (to reduce rabies in wildlife

And, in most instances, when large companies violate national organic standards, the response from Congress, the National Organic Program and the National Organic Standards Board, has been to change the law and regulations to match non-compliance rather than to strengthen enforcement.

The most striking example of this was in 2005 when the Organic Trade Association went to Congress to overturn a federal court ruling in favor of an organic blueberry farmer Arthur Harvey. The original version of OFPA limited the National List exemptions for prohibited substances used in handling to non-organics that were also non-synthetic. When the court in Harvey v. USDA ruled that synthetic ingredients were being illegally approved for use in organic foods, the OTA got Congress to reverse the decision legislatively.

Another more recent example is DHA/ARA. The National Organic Program admitted that these synthetics used in baby formula, baby food and baby cereal, were illegally approved for use in organic foods, but instead of enforcing the law, the NOP asked the manufacturer to petition the products for placement on the National List and the National Organic Standards Board approved them at the last meeting, even though it was clear that the NOP had not properly vetted DHA/ARA to determine whether they were produced using excluded methods of genetic engineering.

Two more examples of the organic industry’s refusal to obey the law — and the NOP’s unwillingness to enforce the law — are open questions before you: GMO vaccines and animal welfare standards.

Under current regulations, GMO vaccines can’t be used unless they are successfully petitioned for use on the National List. To date, no GMO vaccines have been petitioned, so one would assume that they’re not being used in organic.

But, we know they are being used. This was first admitted to publicly by the National Organic Program staff at the May 2009 meeting of the National Organic Standards Board. Richard Matthews announced to the board that, in fact, since the beginning of the program, all vaccines had been routinely allowed in organic, without a review as to whether or not they were genetically engineered, and he recommended that, instead of the NOP enforcing the law against this violation, the NOSB should recommend a change in the law and that’s what the NOSB did.

Deputy Administrator Miles McEvoy wisely rejected that recommendation, but the NOP still hasn’t made any attempt to enforce current law. The NOP should have immediately collected information on which vaccines are being used in organic and prohibited those that are genetically engineered. At that point, prohibited GMO vaccines that had been used in organic could be petitioned. And we’d be back on track with current law.

Instead, the NOP seems to have left the ball in the NOSB’s court. And we still have an acknowledged failure to follow and enforce the law.

This isn’t right. The National Organic Standards Board should stop work on GMO vaccine recommendations until there are assurances from the NOP that they’re going to stop the illegal use of GMO vaccines.

We have a similar problem on the issue of animal welfare. You all are trying hard to establish some measurable standards for animal welfare, but the irony is that while you try to improve animal welfare, the current regulations are being violated.

The pharmaceutical industry, and many doctors, appear to be making great efforts by to get as many people as possible vaccinated against shingles. Even if such an intervention was highly effective in preventing shingles, which certainly has not been shown to be the case, the information below should make it clear that such vaccinations are unnecessary. The side effects that would be suffered by a significant number of individuals need never occur in the first place. The real problem is that what is discussed below generates relatively little income for anybody in the healthcare industry. Regardless, you need to decide for yourself.

Shingles is an infection resulting from the varicella zoster virus, usually manifesting in areas supplied by spinal nerves, known as dermatomes. More commonly known in medical circles as Herpes zoster, the infection is typically characterized by a blistering skin rash of extraordinary pain for most individuals. The initial infection with the virus is usually remote from the shingles outbreak, typically occurring in childhood when chickenpox is contracted. For years the virus remains latent in nerve cell bodies or autonomic ganglia. It is when the virus, for unclear reasons, breaks out of these storage sites and travels down the nerve axons that shingles occurs.

Left to itself along with mainstream therapies that include analgesics, antiviral agents like acyclovir, and corticosteroids, the rash will generally resolve in two to four weeks. The pain is generally lessened little by analgesics. Some unfortunate individuals can experience postherpetic neuralgia, a syndrome of residual nerve pain that can continue for months or years following a shingles outbreak.

Treatment of Shingles with Vitamin C

The clinical response of shingles to vitamin C therapy is decidedly different from its response to traditional therapies. While there are not many reports in the literature on vitamin C and shingles, the studies that do exist are striking. Frederick Klenner, MD, who pioneered the effective use of vitamin C in a wide variety of infections and toxin exposures, published the results of his vitamin C therapy on eight patients with shingles. He gave 2,000 to 3,000 mg of vitamin C by injection every 12 hours, supplemented by 1,000 mg in fruit juice by mouth every two hours. In seven of the eight patients treated in this manner, complete pain relief was reported within two hours of the first vitamin C injection. All patients received a total of five to seven vitamin C injections. Having had shingles myself years before I knew of the efficacy of vitamin C therapy, I can assert that this is nothing short of a stunning result on what is usually a painful and debilitating disease.

At least nine babies have died in China the past few weeks after being injected with the Hepatitis B vaccine.

In China, the Hepatitis B vaccine is given in three stages. The first shot is taken immediately after birth. The second and third shots of the vaccine are taken after a baby is one month and then six months old.

The pharmaceutical company manufacturing the vaccine has conducted quality control tests on the batch currently in the market, and has not found anything wrong with the vaccine. Similar statements have been made by health authorities:

The drug supervision department in Shenzhen says their test results indicate the vaccines were safe.

“According to our investigation, BioKangtai has produced the vaccine strictly under required standards. And their samples have passed our tests.” Wang Lifeng with Drug Administration of Shenzhen said.

The deaths, which have occurred within a very short time after receiving the vaccine, are gaining wide exposure in the China media. Because vaccines are almost always promoted as safe, injuries and deaths often are not associated with the vaccine, so there may be more deaths than have currently been reported. One of the deaths was reported by a family member after hearing about other babies dying shortly after receiving the vaccine in the media. When the family originally was fighting to save the baby from dying, they had not suspected the vaccine.

China Investigates Vaccine Maker After Deaths of Infants

Published: December 25, 2013

SHANGHAI — Health authorities in China are investigating one of the nation’s biggest vaccine makers after eight infants died in the past two months following injections that were meant to immunize them against hepatitis B.

The government said this week that it had suspended the use of millions of doses of a hepatitis B vaccine produced by the manufacturer, Shenzhen Kangtai Biological Products. Government inspectors have been sent to examine the company’s facilities.

Six of the deaths have been linked to vaccines produced by Shenzhen Kangtai; the two other infant deaths occurred recently after the use of a hepatitis B vaccine produced by another drug maker, Beijing Tiantan Biological Products. The government did not say whether any action had been taken against Beijing Tiantan or its vaccines. Investigators have not determined the cause of the deaths or linked them directly to the injections, but the cases come at a time of growing public concern in China about food and drug safety problems.

In recent years, China has been troubled by a series of scandals, including tainted rice and milk and the mysterious appearance of thousands of dead pigs floating in the Huangpu River in Shanghai. China has vowed repeatedly to crack down on food and drug safety violations and has moved to strengthen the powers of health officials.

In the vaccine cases, the government is focusing on the role of Shenzhen Kangtai, a privately run drug maker formed in 1992 with government support and the cooperation of the American pharmaceutical company Merck.

Citing low demand, high costs – and questioning the benefits, Utah’s Public Department of Health does not stock or recommend Gardasil HPV vaccine. The decision to exclude the vaccine from its public health clinics was made by the agency’s director, contrary to the area’s Board of Health.

“The backlash and sentiment against it was strong enough that there’s no reason to go there,” physician David Blodgett explained. “No one wants it and it’s too expensive when we’re not funded to provide it.”

The vaccine isn’t mandated in Utah. But the Utah Department of Health has been recommending it for preteen girls since 2006, and for boys since 2011.

At 42 percent, Utah ranks lowest in the nation for completion of the three-injection series among girls who start it.

Unproven Science and Increasing Reports of Side Effects

Official reasons for the slow uptake are varied, but informed parents who have increasingly become skeptical of vaccination, especially the HPV vaccine are likely making the difference.

The HPV vaccine is possibly the biggest vaccine hoax in the last century. HPV vaccines are nothing more than a worldwide exercise in profiteering at the expense of children’s health. Due to the overwhelming amount of side effects associated with the vaccine, health agencies are now encouraging health professionals not to report adverse reactions, a clear indication that something is very wrong.

Earlier this month, Mr. Jean-Christophe Coubris, defence lawyer for Marie-Oceane, a HPV vaccine injured teen, has filed charges with the French public prosecutor in Bobigny, in the outskirts of Paris, against both Laboratoire Sanofi Pasteur MSD and the French authority Agence Nationale du Medicament (ANSM), the French National Medicines Agency, for breach of their manifest duty to ensure safety and for disregard of the precautionary and prevention principles.

“To be dissuaded by cost issues, or to not stock the vaccine due to low public demand, is disingenuous, especially for someone with responsibilities to protect the public,” said said William Cosgrove, a pediatrician in Murray and a member of the Utah Scientific Immunization Advisory Committee. “I believe the real medical issues here are clouded by a moralistic belief system that precludes any frank discussion about sexuality in adolescents.”

Blodgett cites other problems with Gardasil, namely that it was fast-tracked through the Food and Drug Administration (FDA) and a belief that its benefits were oversold by drug maker Merck.

The study, published in Cancer, reveals the steepest decline in vaccine completion among girls and young women aged nine to 18 — the age group according to medical officials that should receive the vaccine in three doses over six months — a message that has been drilled into parents for just over five years.

“The science wasn’t good… We had physicians in our community arguing that we not make it available,” said Blodgett.

Just two years ago, a publication in the Annals of Medicine exposed the fraudulent nature of Human papillomavirus (HPV) vaccines. Key messages the researchers report include a lack of evidence for any HPV vaccines in preventing cervical cancer and lack of evaluation of health risks. The researchers stated that physicians should adopt a more rigorous evidence-based medicine approach, in order to provide a balanced and objective evaluation of vaccine risks and benefits to their patients.

The Public Isn’t Buying Medical Hype

It’s not the only risk and the vaccine is claimed to cut the risk by only 17 percent. Cancers caused by HPV are extremely rare and vaccination comes with no guarantee for long-term protection and high risk of side effects.

Weighed against the vaccine’s risks, “the public isn’t buying it,” said Blodgett. “It’s eroding public trust in immunization programs.”

“It’s a complicated vaccine that requires discussion about [sexual health] and a physical exam and follow-up visits with a doctor,” said the agency’s director, Joseph Shaffer. “My feeling is that’s better held in the physician’s office than here at the health department.”

Fear that Gardasil is dangerous hasn’t been eased by the FDA’s assurances. The agency approved and monitors the drug and says its safety profile matches those of other vaccines, but the evidence that continues to coming forward from the U.S. and around the world are proving different.

In this excerpt from the new book Crony Capitalism in America 2008-2012, Hunter Lewis exposes the incestuous relationship between government and the drug industry.

Lewis, who serves as president of ANH-USA’s board of directors, has written nine books on moral philosophy, psychology, and economics, including the widely acclaimed Are the Rich Necessary? (which the New York Times called “highly provocative and highly pleasurable”). He has contributed to the New York Times, the Times of London, the Washington Post, and the Atlantic Monthly, as well as numerous websites such as Forbes.com and RealClearMarkets.com.

In his new book, Lewis shows how private interests and politicians rely upon one another—political favors in exchange for money—a system known as crony capitalism. Where do private interests such as those on Wall Street or in the drug industry stop and Washington begins? It’s impossible to say anymore.

Chapter 15 is all about the FDA, and we thought our readers would enjoy this searing behind-the-scenes look at just how deeply the US Food and Drug Administration has enmeshed itself with the pharmaceutical industry:

Big Pharma and FDA:
A Marriage Not Made in Heaven

The drug industry at one time was called the patent medicine industry. This is still the more revealing name. Drug companies devote themselves to inventing non-natural molecules for use in medicine. Why non-natural? Because molecules previously occurring in nature cannot, as a rule, be patented. It is essential to develop a patentable medicine; only a medicine protected by a government patent can hope to recoup the enormous cost of taking a new drug through the government’s approval process.

Getting a new drug through the US Food and Drug Administration (FDA) is not just expensive ($1 billion on average). It also requires having the right people on your side. Drug companies know that they must hire former FDA employees to assist with the process. They also hire leading experts as consultants, some of the same experts who may be called on by the FDA to serve on its screening panels. Direct payments must also be made to support the FDA’s budget.

All these financial ties encourage a “wink and a nod” relationship between researchers working for drug companies and regulators, who are often the same people, thanks to the revolving door. As the Economist magazine writes:

Pharmaceutical companies bury clinical trials which show bad results for a drug and publish only those that show a benefit. The trials are often run on small numbers of unrepresentative patients, and the statistical analyses are massaged to give as rosy a picture as possible. Entire clinical trials are run not as trials at all, but as under-the-counter advertising campaigns designed to persuade doctors to prescribe a company’s drug.

The bad behavior extends far beyond the industry itself. Drug regulators, who do get access to some of the hidden results, often guard them jealously, even from academic researchers, seeming to serve the interests of the firms whose products they are supposed to police. The French journal Prescrire applied to Europe’s drug regulator for information on the diet drug rimonabant. The regulator sent back 68 pages in which virtually every sentence was blacked out. . . .

Medical journals frequently fail to perform basic checks on the papers they print, so all sorts of sharp practice goes uncorrected. Many published studies are not written by the academics whose names they bear, but by commercial ghostwriters paid by drug firms. Doctors are bombarded with advertising encouraging them to prescribe certain drugs. . . .

What the Economist calls “bad behavior” also spills over from the medical world to the financial world. Just since 2008, 75 people have been charged with trying to profit from inside information about drug approvals or company mergers related to patentable drugs. One of them, an FDA chemist named Cheng Yi Liang with access to the Agency’s approval database, pleaded guilty to insider trading on 25 companies for a total gain of $3.78 million over five years. Others with larger resources to invest have made much larger sums. Rod Rothstein, the US Attorney for Maryland who helped prosecute the FDA case, has noted that “healthcare is particularly attractive to criminals because so much turns on government regulatory approval.”

Dr. Ben Goldacre, author of Bad Pharma, summarizes the entire drug approval process as follows: “[It] is broken. . . . The people you should have been able to trust to fix [the] problems have failed you.”

Although the costs of drug approval keep growing, along with the related corruption, the financial payoff for those ultimately winning approval can be astronomical, because approval also brings with it a government-protected monopoly. Only FDA-approved drugs can be prescribed within government programs such as Medicare. Doctors may prescribe unapproved substances outside of Medicare, Medicaid, or the Veteran’s Administration, but by doing so risk losing their license to practice. Some approved drugs may be priced as high as $500,000 per year per patient.

The FDA will also discourage, and often ban, substances that might compete with approved drugs. When anti-depression drugs (based on extending the life of a hormone, serotonin, inside the body) were approved, the Agency promptly banned a natural substance, L-Tryptophan, that increased serotonin, even though the natural substance was much cheaper and had long been available. Many years later, after the anti-depression drugs were well established, Tryptophan was finally allowed back, but under restrictions that made it more expensive.

In general, the FDA maintains a resolutely hostile stance toward supplements. It will not allow any treatment claims to be made for them, no matter how much science there is to support it, unless they are brought through the FDA approval process and thus become drugs. The Agency understands that this is a classic “Catch-22.” Who can afford to spend up to a billion dollars to win FDA approval of a non-patented substance? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the Agency’s bills.

This FDA policy prevents millions of Americans from hearing about food or supplement remedies that are safer and cheaper than drugs. It hurts the poor and the middle class. But, ironically, it also hurts the rich, even the crony capitalist rich. A national magazine ran a profile of a Wall Street billionaire sitting in his gigantic Connecticut mansion, popping acid blockers for a stomach problem that tormented him. He was totally unaware of research suggesting that most such ailments stemmed from too little acid, not too much, and that a few simple tablets containing hydrochloric acid, one of the cheapest supplements, would probably end his pain.

Why did the billionaire not know this? The answer could not be simpler: crony capitalist drug companies earn huge profits from acid blockers, and along with their friends in government at the FDA, succeed in keeping this information hidden. So there the billionaire sits in his great mansion, unable to enjoy it because of intense stomach pain.

Drug companies and the FDA are not alone in wishing to suppress supplement alternatives to hyper-expensive patented prescription drugs. They have allies among both politicians and doctors. For example, the Archives of Internal Medicine, run by the American Medical Association, and supported financially by drug companies, often publishes flimsy studies attacking supplements, and generally ignores the considerable scientific evidence in their favor.

One such study, published October 10, 2011, by University of Michigan researchers, purported to show that taking supplements could shorten your life. It caused a media feeding frenzy, with headlines everywhere. The problem was that this study, like its predecessors, was junk science. The women in the study were asked every six years what they had taken. They were supposed to remember what they had taken for the six-year period. The reports did not have to be specific: the word “multivitamin” could mean anything. Who knows what was taken or even it if was taken? It could also be synthetic or natural.

Those who reported taking “multivitamins” were found over time to be healthier on average than others and to live longer. But the authors of the study, who clearly had an anti-supplement agenda, made numerous “adjustments” attributing the good health to other factors. Once these arbitrary “adjustments” were made, they then concluded that supplements actually made these healthier than average and longer living people unhealthier. Even after the “adjustment,” the statistical evidence was weak to nonexistent, but that did not prevent media from all over the world reporting that supplements may hasten your death.

What was behind this? The AMA seems worried about competition for its brand of medicine, which focuses almost exclusively on conventional drugs and surgery. It is especially worried about competition from “integrative” doctors who include advice about food, supplements, and exercise in their practice. The AMA and its affiliates also have a tight relationship with drug companies, and depend on them for financial support in many forms, not just journal advertising. Both the AMA and drug companies thus seem determined to trash supplements and those giving advice on supplements.

Dr. John Rengen Virapen worked 35 years for Eli Lilly & Co as an executive. He now speaks out on the many crimes Big Pharma was and is responsible for and he himself also participated in. Unfortunately, many of its crimes go passed public awareness as it enjoys the unethical protection from its big allies, the mainstream media, the FDA and governments.

A New York State school has terminated the rights of a child to attend classes solely on the basis of being unvaccinated. This despite the advice of her Physician who stated that it could kill her. A devout Catholic mom has now filed a lawsuit against the State government. Read her story:

Mary is almost six and a half years old, and she enjoys going to school, dancing, singing, swimming, and playing with her sister and friends. Today I looked at her beautiful face smiling while she was playing with her dolls, and I can’t believe how far we have come since the day she was born and how blessed I am to call her mine. At first glance, you wouldn’t know the battles that she has been through.

When Mary was born I didn’t know what ingredients were put into vaccinations, just like most parents. I was brainwashed into thinking that I must vaccinate my child since this is what U.S. social norms say that we as parents are supposed to do for our children. So Mary was vaccinated like every other typical newborn in this country. After each vaccination, she would have a negative reaction. At that point, the medical professionals did not know what was wrong with her, but looking back now we know that it was two DTaP vaccines that she received on July 9th, 2007 and August 13th, 2007.

She ended up being completely overwhelmed with thrush and intestinal yeast toxins after it had nowhere else to go in her tiny, little less-than-five-pound body. Mucus was leaking out of her eyes, vagina, and her rear end was red like it was put over a flame of fire. My daughter was not absorbing her nutrients, and she wasn’t growing. On the way home from a vaccination appointment, when she received her Comvax immunizations on August 29th, 2007, Mary was crying and nothing would console her. Her same symptoms came back that she experienced from her DTaP vaccinations. The combination of yeast and negative organisms ended up causing a double ear infection as well.

The doctor had prescribed her a compounded suppository antibiotic because that is the protocol for healing an ear infection in NY State, but, in Mary’s case, it was a disaster and caused more damage to her immune system — just like every other unnatural substance that was given to her. We administered the medicine to her at home as instructed, but less than twenty seconds later Mary went into anaphylactic shock. She started vomiting, convulsing, water was pouring out of her rectum, and her eyes rolled into the back of her head. Everything was happening so quickly, I couldn’t reach the phone to call 911. My first reaction was to cry out to the Lord, “In the name of Jesus, save my baby!” All of a sudden, the vomiting stopped and the color came back into her face. Her eyes were looking at us, she was breathing normally and a peace and calmness came over her. The only one who could save us and rescue Mary so swiftly during that crisis was Our Heavenly Father, and that is just one of the many miracles that my family has experienced through the Lord, Jesus Christ.

After years of testing and treating her, we now know that she has an overactive immune system. Due to Mary’s overactive immune system, she cannot tolerate any preservatives or artificial ingredients. Mary has a severe gluten sensitivity and is allergic to casein, etc. She is on an all-natural diet, and on a strict regimen to help support and strengthen her gastrointestinal tract and immune system. Dyes, preservatives, and unnatural substances all make her violently sick. She is brave and remains strong through her struggles because of her faith in God and the positive people that are put in our path. We are all very proud of her.

In 2010 we applied for a religious exemption from vaccinations and were guaranteed by the director of the school that everything was set and she would be able to attend school because of her religious exemption. In 2012, Mary’s health took a turn for the worse and, after being hospitalized, our family doctor told me that Mary qualified for a medical exemption. He said that vaccination would compromise her immune system and stated that “It is my medical opinion that Mary Check cannot tolerate any insults, in even the slightest amounts, to her immune system without putting her at risk for anaphalaxis, which include, vaccines, medications, and certain foods.” Still with the religious exemption in place, I didn’t think it was necessary to apply for a medical exemption as well, just yet, since I was told that the religious exemption was acceptable. When Mary entered kindergarten, I spoke with the principal of the elementary school and told her about my medical and religious exemptions, so she could get to know Mary’s situation. I told the principal that I would be using Mary’s religious exemption, but I also gave her my medical exemption application to put on file as well, because I was new to the public school system and didn’t know what they needed. I trusted the school system and they failed me. In October, that medical exemption application that I did not want to be filed was mysteriously handed into the Board of Health. In fact, I did not even apply for a medical exemption. The medical exemption application resulted from a clerical error. I was told that I would be able to proceed with a religious exemption, but, when I went to the school to address the situation, it was too late.

I was denied within 24 hours of application. Even though this medical exemption was not meant to go through at this point in time, Mary was denied her medical rights and she was kicked out of school. I was accused of trying to skirt around my denied medical exemption by applying for a religious exemption; the fact that I applied for a religious exemption in 2010 was completely ignored. I had to go to federal court to prove that my religious exemption was legitimate and to sue the Board of Education. My daughter’s medical issues are what made me pick up my Bible and read it every day and drew me closer to my beliefs that God made the body perfect and pure, and I don’t want to put any impurities into her body based on my deepest truths, which comes from the word of the Lord.

While I believe that doctors are here to help heal the sick and I value their place on this earth, I do not have blind faith in medical professionals. They are human beings, and we are told by the Lord that we are not to put our complete faith in anyone else but Him. I respect my pediatrician’s advice, but, ultimately, I have to base my informed decisions on my own research, my faith, and my instincts as a parent. I get a diagnosis from the doctor and it does not go ignored. We work together on treating Mary to suit her needs. I have researched what poisons are put into these vaccinations, and I do not believe that it is God’s will to put them into our bodies. Immunizations contain unnatural substances that are injected into the bloodstream.

Winning this case will set new case law, but I am completely financially depleted in my battle, and I need your help in this fight for freedom. Mary represents the many children in the United States in need of legal representation to protect their health and safety. In supporting Mary’s choice, you are supporting parents’ and doctors’ rights to choose what is in the best interest of their children and patients. Whether or not you are pro-vaccination or pro-vaccination choice, this cause deals with the right of a parent to choose or refuse what vaccinations are given to their children. All parents should have the right to choose what kind of medical treatment their children should receive, and, if a person has religious beliefs contrary to a medical treatment, our constitutional right to the free exercise of religion should be protected and not subject to the review of one person, as it is in the New York City Department of Health and Mental Hygiene.

What touched me so close to my heart is when Barbara Loe Fisher, president of the National Vaccine Information Center (NVIC) said, “We as parents, who know and love our children better than anyone else, we by U.S. law and a larger moral imperative, are the guardians of our children until they are old enough to make life and death decisions for themselves. We are responsible for their welfare, and we are the ones who bear the grief and the burden when they are injured or die from any cause. We are their voice and, by all that is right in this great country and in the moral universe, we should be allowed to make a rational, informed, voluntary decision about which diseases and which vaccines we are willing to risk their lives for without fearing retribution from employees of the state.” Argue with us. Educate us. Persuade us. But don’t track us down and force us to violate our moral conscience and beliefs, or criticize our doctors’ professional opinion in the medical approach they choose to take, putting the best interest of their patients first.

On October 10th, 2013 Support Mary’s Rights will be hosting a fundraising dinner and dance at Li Greci’s Staaten to help not only raise money to support the Mary’s legal efforts in her fight against the New York Board of Education and the Supreme Court but also to raise awareness about the vaccinations parents and doctors are forced to give to their children and patients, regardless of the ingredients or harmful affects they may cause.

Support Mary’s Rights would appreciate your charitable contribution. A monetary donation or donated gift certificates or items to raffle off would truly help this very unique and special cause. I need my voice to be heard for myself and other families who are suffering from similar experiences where the government is trying to tell us what we mandatorily have to put into our bodies. Our faith as parents leads us to take physical, spiritual, and mental responsibility and make decision for the health and well being of our children. The government is trying to take away these rights as parents. Come to our fundraiser and share your stories with us. We would love to hear them and to support you as well! Buy a table and support us at: http://www.supportmarysrights.com/events.html

In return for your generosity Support Mary’s Rights will be printing the names of each business involved in our Support Mary’s Rights program booklet. Thank you for taking the time to read this blog post. We hope you consider making a donation/ contribution. If you have any questions or need further information, please feel free to contact me or visit our website at www.supportmarysrights.com. Or call 917-554-1988

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New Minnesota State Law Bans Cancer-Causing Formaldehyde in Children’s Products, Stays in Vaccines

Formaldehyde is banned in children’s products while a loophole is created for vaccines.

Lawmakers in the state of Minnesota have decided formaldehyde, a known cancer-causing agent, is too dangerous for children’s products. According to section 325F.175 of HF458, products containing formaldehyde are banned from being sold starting August 1st, 2014, for manufacturers and August 1st, 2015, for retailers. [1]

Finally, an answer to one of the many toxic ingredients being injected into your child?

Not so fast.

At first blush, it appears Minnesota is addressing at least one of the many toxic chemicals found in vaccines. However, a carefully crafted paragraph creates a loophole for excluding vaccines from this ban.

The Pharmaceutical Loophole

So, how is formaldehyde banned in toys and clothes but permitted to still be in vaccines? The new Minnesota state law exempts vaccines through this passage in a section entitled “[325F.174] DEFINITIONS.”

It reads:

“(c) “Children’s product” means a product primarily designed or intended by a manufacturer to be physically applied to or introduced into a child’s body, including any article used as a component of such a product and excluding a food, beverage, dietary supplement, pharmaceutical product or biologic, children’s toys that are covered by the ASTM International F963 standard for Toy Safety, or a medical device as defined in the federal Food, Drug, and Cosmetic Act, United States Code, title 21, section 321(h), as amended through February 15, 2013.” [1] (emphasis mine)

Frankly, I’m puzzled. Lawmakers don’t want your child to play with or put into their mouth products containing formaldehyde, but if your doctor injects it into your baby, it is perfectly fine?

Let’s Look at Which Vaccines Contain Formaldehyde

You may be asking, “Why is there formaldehyde in vaccines?”

The very short answer is this chemical has been used for over half a century in the vaccine manufacturing process. It was originally used as an attempt to inactivate the poliovirus in the first vaccines produced by Jonas Salk in the late 1940s and early 1950s. [2]

Formaldehyde did not inactivate all viruses in the vaccine. Do more research on the polio vaccine contamination with the cancer causing monkey virus, SV40.

After the polio vaccine, formaldehyde was heavily used in manufacturing pediatric vaccines.

To see how many vaccines contain this cancer-causing chemical today, let’s take a look at the Children’s Hospital of Philadelphia website. The formaldehyde content of vaccines licensed for use in the United States (quantity per dose converted from mg to mcg): [3]

A stunning new report reveals that the United Nations Children’s Fund (UNICEF) has been monitoring independent health sites and their users in an attempt to identify ‘anti-vaccine influencers’ and their effect on lackluster vaccine uptake.

Opening with the Mark Twain quote: “A lie can travel halfway around the world while the truth is putting on its shoes,” the report lists the following ‘anti-vaccine influencers’ shaping the online conversation:

UNICEF’s opening reference to the “lie” (misinformation) spread by the above-mentioned web-based organizations indicates that while the document purports to be analytical and descriptive, it has proscriptive and defamatory undertones, and only thinly conceals an agenda to discredit opposing views and voices.

UNICEF’s derogatory stance is all the more surprising considering that websites such as GreenMedinfo.com aggregate, disseminate and provide open access to peer-reviewed research on vaccine adverse effects and safety concerns extracted directly from the US National Library of Medicine, much of which comes from high-impact journals. [see data set here: vaccine research ]. In turn, websites such as Mercola.com and NaturalNews.com often simply cite the same data and report on its implications.

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